AIDS Education and Prevention, 26(2), 144–157, 2014
© 2014 The Guilford Press
Pedro Mateu-Gelabert, Honoria Guarino, Milagros Sandoval, and Samuel R. Friedman are with National
Development Research Institutes, Inc., New York, New York. Marya Viorst Gwadz, Charles M. Cleland,
Ashly Jordan, and Holly Hagan are with the New York University College of Nursing, New York, New
York. Howard Lune is with Hunter College of the City University of New York, New York, New York.
The project described was supported by award numbers R21DA026328, R01DA019383, R01DA031597,
and R01DA035146 from the National Institute on Drug Abuse. The content is solely the responsibility of
the authors and does not necessarily represent the official views of the National Institute on Drug Abuse
or the National Institutes of Health.
Address correspondence to Pedro Mateu-Gelabert, Ph.D., NDRI Inc., 71 W. 23rd St., 4th fl., New York,
NY 10010. E-mail: firstname.lastname@example.org
STAYING SAFE INTERVENTION
MATEU-GELABERT ET AL.
THE STAYING SAFE INTERVENTION:
TRAINING PEOPLE WHO INJECT DRUGS IN
STRATEGIES TO AVOID INJECTION-RELATED
HCV AND HIV INFECTION
Pedro Mateu-Gelabert, Marya Viorst Gwadz, Honoria Guarino,
Milagros Sandoval, Charles M. Cleland, Ashly Jordan, Holly Hagan,
Howard Lune, and Samuel R. Friedman
This pilot study explores the feasibility and preliminary efficacy of the
Staying Safe Intervention, an innovative, strengths-based program to
facilitate prevention of infection with the human immunodeficiency virus
and with the hepatitis C virus among people who inject drugs (PWID). The
authors explored changes in the intervention’s two primary endpoints: (a)
frequency and amount of drug intake, and (b) frequency of risky injection
practices. We also explored changes in hypothesized mediators of interven-
tion efficacy: planning skills, motivation/self-efficacy to inject safely, skills
to avoid PWID-associated stigma, social support, drug-related withdrawal
symptoms, and injection network size and risk norms. A 1-week, five-
session intervention (10 hours total) was evaluated using a pre- versus
3-month posttest design. Fifty-one participants completed pre- and posttest
assessments. Participants reported significant reductions in drug intake and
injection-related risk behavior. Participants also reported significant in-
creases in planning skills, motivation/self-efficacy, and stigma management
strategies, while reducing their exposure to drug withdrawal episodes and
risky injection networks.
Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection among
people who inject drugs (PWID) are significant and persistent public health chal-
lenges. The Centers for Disease Control and Prevention (CDC) estimate that in the
United States 9% of new HIV infections can be attributed to injection drug use
(Prejean et al., 2011), and 18% of PWID are HIV positive. In contrast, PWID make
STAYING SAFE INTERVENTION 145
up the majority of persons with HCV infection in the United States, and HCV preva-
lence among PWID has been estimated at 70%–77% (Hagan, Pouget, Des Jarlais,
& Lelutiu-Weinberger, 2008). Although syringe exchange programs (SEPs), opioid
substitution therapy (OST), and other harm reduction programs have been shown to
reduce parenteral HIV transmission among PWID in locations where they have been
implemented to scale, their effect on HCV transmission has been less conclusive and
of smaller magnitude. A number of social/behavioral interventions have reduced
syringe sharing, but they have had less success in preventing the sharing of other
injection equipment, such as cookers, cotton filters, and water, behaviors that have
been shown to efficiently transmit HCV (Doerrbecker et al., 2013; Hagan, 2011;
Hagan et al., 2001; Mateu-Gelabert et al., 2007). In recent research (Friedman,
Mateu-Gelabert, Sandoval, Hagan, & Des Jarlais, 2008; Friedman, Mateu-Gelabert,
Sandoval, & Meylakhs, 2013; Friedman, Sandoval, Mateu-Gelabert, Meylakhs, &
Des Jarlais, 2011; Mateu-Gelabert, Sandoval, Meylakhs, Wendel, & Friedman,
2010; Vazan, Mateu-Gelabert, Cleland, Sandoval, & Friedman, 2012), our team has
sought to understand factors underlying persistent injection risk behavior among the
PWID population, as described in this article.
In 2005 we conducted a study, entitled Staying Safe, to examine the behaviors
and strategies of individuals who had injected drugs for long periods of time (8–15
years) but had not contracted HIV or HCV. The study was based on the assumption
that identifying the social and structural resources these individuals either accessed
or created, along with the specific protective behaviors and routines they developed,
would provide valuable guidance for future HIV and HCV prevention programs for
PWID. The Staying Safe study utilized a “positive-deviance control-case life history”
approach (Friedman et al., 2008) to examine the life histories, social and structural
contexts, and pragmatic strategies of these HIV/HCV-negative (i.e., “doubly unin-
fected”) PWID as compared to their HIV- and/or HCV-infected counterparts. We
found support for many of the standard approaches to HIV and HCV risk reduc-
tion, such as avoiding injecting with used syringes or other injection equipment.
Furthermore, we found that doubly uninfected PWID aimed to achieve “symbiotic
goals”—that is, goals not directly focused on disease prevention but that nonetheless
facilitate disease prevention. For example, these symbiotic goals included strategies
such as planning ahead to have access to sterile injection equipment and avoid unsafe
injection locations; managing drug intake to better control drug dependence, there-
by avoiding major pitfalls such as job loss, engaging in crime, or burdening partners
or family members; and avoiding drug withdrawal states that tend to undermine
personal norms and social prohibitions against syringe sharing. Furthermore, we
found social and situational factors to be critical in protecting against injection risk.
Specifically, maintaining social support from nonusers played an important role in
reducing risk, as did minimizing the size of one’s injection network (Friedman et al.,
2011). Highlighting the important role that macrolevel sociostructural factors play
in shaping risk behavior of PWID (Rhodes, 2009), we also found that changes in lo-
cal contextual factors, such as decreased availability of sterile syringes and increased
policing activity, can promote risky injection behavior (Cooper, Moore, Gruskin,
& Krieger, 2005; Des Jarlais, 2000; Mateu-Gelabert et al., 2010). These findings
suggest that preventing HIV and HCV among PWID over the long term will be
strengthened by a multilayered approach that addresses proximate, individual-level
risk behaviors and symbiotic goals as well as “upstream” risk factors, including so-
cial networks and larger structural/environmental contexts.
146 MATEU-GELABERT ET AL.
THE STAYING SAFE INTERVENTION
Building on these findings, we developed a pilot social/behavioral intervention for
PWID, the Staying Safe Intervention, which is directly grounded in lessons learned
from injectors who avoided HIV and HCV infection over long periods of time. The
Staying Safe Intervention seeks to reduce injection risk by intervening upstream in
the causal chain of risk behaviors by modeling, training in, and motivating the use
of strategies and practices of long-term risk avoidance. The intervention’s overarch-
ing theoretical framework is Ecosocial theory (Krieger, 1994, 2001), which posits
that disease risk is conferred through interactions between persons and their social
environment. The Staying Safe Intervention is also informed by the Symbiotic Model
of Risk Reduction (Friedman et al., 2011), which emphasizes that implementing and
attaining certain goals not directly focused on disease prevention (e.g., maintaining
social relations, maintaining housing) can have a “symbiotic effect” on disease pre-
vention by reducing transmission risk. Lastly, the Staying Safe Intervention’s concep-
tualization of the behavior change process is grounded in Social Action Theory (SAT;
Ewart, 1991), an integrative social-cognitive model that identifies and targets spe-
cific individual and social processes to, in this case, reduce upstream determinants of
risk and encourage injection risk–related health-protective behaviors. In SAT, health
habits are framed as an organized system comprising routinized sequences of ac-
tions, consequences, and reactions that lead to predictable outcomes. These routines
are typically socially interdependent—that is, interlinked with the behavior of oth-
ers. To encourage behavior change, SAT seeks to enhance both the social interac-
tion processes that drive or maintain upstream determinants of health (e.g., skills
to maintain social relationships) and the individual determinants of health-related
behavior, such as risk-reduction knowledge, motivation/self-efficacy for behavior
change, and behavioral skills (e.g., planning). A summary of the Staying Safe Inter-
vention’s theoretical model and targeted outcomes is presented in Figure 1.The inter-
vention sessions are summarized in Table 1. (The Staying Safe Intervention manual
is available from the first author.)
FIGURE 1. Staying Safe Intervention Model and Targeted Outcomes.
STAYING SAFE INTERVENTION 147
TABLE 1. Specific Content of the Staying Safe Intervention Sessions (Total of 5 Sessions With Activities)
Group Session 1: Applying Knowledge About HIV and HCV Transmission to Injection Equipment Use
SAT Theoretical Targets: Knowledge, Motivation/Self-Efficacy
Orient to study goals and “Staying Safe” approach Identify at least five injecting situations leading to risk of
HIV/HCV for injection drug users (IDUs)
Review basics of HIV/HCV transmission and prevention
in the context of IDU
Identify role of syringe exchange programs (SEP) and
opioid-replacement therapy (ORT) in risk reduction, and
identify barriers to SEP and ORT for IDUs
Identify practices that put IDUs at risk for HIV and/or
Set preliminary personal risk reduction goals (which will be
revised through the intervention)
Group Session 2: The Injection Ritual and Avoiding Cross-Contamination of Equipment
SAT Theoretical Targets: Knowledge, Motivation/Self-Efficacy
Identify specific ways that cross-contamination of
injection equipment can occur
Identify specific injecting risk situations that lead to risk
Identify cross-contamination risks specific to IDUsIdentify specific strengths that IDUs can use to lower the
risk of viral transmission for themselves, their immediate
colleagues, and the larger community
Define meaning and value of an “injection safety zone”Revisit preliminary personal risk reduction goals (revised
through the intervention)
Group Session 3: Upstream Threats to Safe Injection and Strategies to Overcome Them (Part 1)
SAT Theoretical Targets: Knowledge, Motivation/Self-Efficacy, Skills, Social Interaction Processes relevant
to upstream targets
Identify upstream contexts, situations, and circumstances
that cause serious threats to safe injection
Identify specific skills and strategies to overcome the
injection risks posed by the following situations: dope
sick; needle shortages; homelessness/unstable housing;
losing social ties with nonusers; facing stigma by not
taking care of yourself; losing a job or other steady
income; and arrest, incarceration, and release
Understand how these upstream contexts, situations, and
circumstances can lead to unsafe injection practices
Revisit preliminary personal risk reduction goals (revised
through the intervention)
Group Session 4: Upstream Threats to Safe Injection and Strategies to Overcome Them (Part 2)
SAT Theoretical Targets: Knowledge, Motivation/Self-Efficacy, Skills, Social Interaction Processes relevant to upstream
Use facilitators and peers to model skills and strategies
identified in Session 3 to overcome injection risks
Plan how to apply these skills and strategies in the context
of personal goals
Practice these skills and strategies
Group Session 5: Thinking Strategically and Planning Ahead
SAT Theoretical Targets: Knowledge, Motivation/Self-Efficacy, Skills, Social Interaction Processes
Learn how to strategically plan ahead to avoid potential
threats in the near future
Plan how to integrate HIV and HCV maximum risk
reduction practices into injection networks
Identify concrete action steps to maintain safe injection
and safe sex over the long term, even if confronting
Identify five specific ways to make injection networks safer
from HIV and HCV transmission
Describe specific solutions to challenges that could
impede action steps
Revisit and refine personal risk reduction goals in the
context of “lessons learned” during the intervention
The primary aim of this exploratory pilot study was to provide preliminary evi-
dence of the feasibility and efficacy of the Staying Safe Intervention (five 2-hour ses-
sions), a strengths-based social/behavioral intervention conducted with small groups
of PWID that is designed to facilitate long-term prevention of HIV and HCV. First,
we explored changes in the intervention’s two primary endpoints: (a) the frequency
and amount of drug intake, and (b) the frequency of risky injection practices. Sec-
ond, we explored potential changes in hypothesized mediators of intervention ef-
148 MATEU-GELABERT ET AL.
ficacy, namely, planning skills, motivation/self-efficacy to engage in safe injection
practices (e.g., not sharing equipment with injection partners). skills to avoid PWID-
associated stigma, social support, drug-related withdrawal symptoms, and injection
network size and risk norms. Importantly, the intervention strives not simply to pro-
vide injectors’ with basic risk-reduction knowledge, but also to enhance injectors’
ability to apply this knowledge in real-world contexts.
Because the Staying Safe Intervention was a newly developed, not yet tested
intervention, an early-stage study utilizing a pre- versus 3-month posttest trial de-
sign was conducted to determine whether the intervention was feasible, acceptable
to participants, and showed preliminary evidence of efficacy. Future research will
evaluate this intervention with a larger sample in a randomized, controlled trial.
Snowball sampling of participants began with eight participants directly re-
cruited from two sources: an SEP that provides syringe exchange, outreach, mobile
health services, case management, and peer support groups to PWID; and a large
research study of acute HCV infection among high-risk street-recruited injectors.
Both of these recruitment sites are located in the Lower East Side neighborhood of
Manhattan, an area with a high HCV prevalence among PWID (Diaz et al., 2001).
These eight participants then recruited 60 eligible peers.
Eligibility criteria for participation in the study included being age 18 years or
older, injecting drugs for at least a year, and showing evidence of visible track marks
to confirm status as an injector. Participants were compensated $15 for completing
the pretest assessment, $30 for completing the postintervention assessment, and $25
for each intervention session attended. Project activities were approved by the Insti-
tutional Review Board at the National Development and Research Institutes, Inc.,
and by the collaborating SEP.
ASSESSMENT AND INTERVENTION PROCEDURES
Participants first completed a structured, pretest assessment that measured so-
ciodemographic characteristics, sexual and drug use behaviors, drug use/injection
networks, social support, and external and internal norms. The 45- to 60-minute
computer-assisted, interviewer-administered assessment was conducted in a confi-
dential setting at the study field site using the Questionnaire Development Systems
software program (QDS; Nova Research Company, Bethesda, MD).
All participants were invited to attend the Staying Safe Intervention program,
which consists of five 2-hour small-group (10–12 individuals) sessions guided by a
structured manual. Intervention sessions were led by a professional group facilitator
at the study field site. The first intervention session was conducted approximately 2
weeks after the pretest assessment, with the subsequent four sessions scheduled on
consecutive days thereafter. Seventy-five percent (51/68) of the participants com-
pleted the posttest assessment. Reasons for losses to follow-up included traveling
outside New York State and incarceration.
STAYING SAFE INTERVENTION 149
All assessment instruments listed here, except for the measure of injection risk
behavior, were developed by our research team in a prior study. The psychometric
properties of these newly developed scales are described in Vazan et al. (2012).
Participant Sociodemographics. Gender, age, race/ethnicity, education level, age of
first injection, and housing status were assessed at pretest. All other constructs (listed
here) were assessed at pretest and 3 months postintervention in reference to the
3-month period prior to the assessment. Unless otherwise noted, responses were as-
sessed using a 5-point Likert-type scale anchored by 0 = Never and 4 = Very Often.
Mediating Factors: Individual Determinants of Risk. Planning Ability to avoid in-
jection-related risk was assessed using a seven-item instrument, (Cronbach’s alpha
= .82), which included items on (a) planning to avoid unaffordable drug intake; (b)
planning to avoid drug withdrawal; (c) drug use interfering with responsibilities;
and planning strategies to (d) lead a “normal” life; (e) maintain a “decent” physical
appearance; (f) ensure steady access to sterile injection equipment; and (g) injecting
in safe locations and avoiding unsafe ones.
Motivation/Self-Efficacy to avoid sharing drug injection paraphernalia was
measured with an adapted five-item Self-Efficacy scale (Vazan et al., 2012; Cron-
bach’s alpha = .90) that assessed the extent to which participants felt they could suc-
cessfully avoid sharing (a) needles, (b) cookers, (c) cottons, and (d) rinse water when
injecting with people they knew and (e) could avoid using an injection partner’s
syringe, even if they had previously shared injection equipment with that person.
Responses were scored on a 5-point Likert-type scale anchored by 0 = not at all true
and 4 = extremely true.
Mediating Factors: Upstream Determinants of Risk. Efforts to Minimize PWID-As-
sociated Stigma was assessed with a 10-item scale (Keeping It Together scale; Cron-
bach’s alpha =.82) covering three domains: living a normal life [efforts to (a) live a
normal life; (b) manage drug use; (c) think of things other than drugs; (d) maintain
personal hygiene; (e) pay back borrowed money]; taking care of veins [(f) avoiding
track marks caused by injection; (g) hiding track marks; (h) preventing abscesses; (i)
avoiding crack/cocaine injection], and distancing oneself socially from other injec-
tors [(j) hanging around known injectors in one’s own neighborhood].
Social Support was assessed using an Access to Resources scale (Cronbach’s
alpha = .80). This 9-item scale assesses social support received from relatives, no-
nusing friends, and neighbors in three support subcategories: material support [(a)
provided a place sleep; (b) gave money; (c) loaned money; (d) gave recommendations
for work]; emotional support [provided emotional support (e) when unhappy and (f)
when in trouble with the law]; and drug use–related support [(g) recommended drug
treatment; (h) helped to cope with withdrawal; (i) supplied with sterile syringes].
Mediating Factors: Risk Contexts. A third set of targeted outcomes captured par-
ticipants’ exposure to situations that are likely to increase their risk of blood-borne
infection. Experiencing drug withdrawal is a particularly high-risk context, because
users who normally maintain safe injection practices may override their own inter-
150 MATEU-GELABERT ET AL.
nalized norms in order to overcome the acute physical and psychological discomfort
associated with opioid withdrawal. Other known risk contexts for PWID include
injecting with a high number of injection partners, having access only to syringes
used by others, and being in a drug-use situation in which the only syringes available
are those that have been previously used by others.
Efforts to prevent drug withdrawal states were assessed using a 5-item With-
drawal Prevention Tactics scale designed for this study (Cronbach’s alpha = .61).
Specific items ask respondents, with reference to the previous 3 months, how fre-
quently they (a) save a bag for the next morning; (b) put aside additional drugs;
(c) store methadone; (d) put aside money for drugs in an emergency; and (e) use
painkillers or other drugs to ease withdrawal symptoms. We elected to use this With-
drawal Prevention Tactics scale despite the modest internal consistency because our
prior research has indicated that PWID are more likely to engage in injection-related
risk behaviors when experiencing withdrawal (Mateu-Gelabert et al., 2010), and, to
our knowledge, no alternative measures to assess this construct exist.
Exposure to drug withdrawal states was assessed by asking participants how
many times they had experienced withdrawal in the past 3 months. Responses were
coded as follows: 0 times = 0; 1–5 times = 1; 6–10 times = 2; 11–20 times = 3; 21
or more times = 4. For analysis, responses were recoded as a dichotomous vari-
able: “exposure to 0–5 withdrawals” and “exposure to 6 or more withdrawals.”
Our prior qualitative research (Mateu-Gelabert et al., 2010) indicates that most opi-
oid-dependent injectors in our target population experience numerous withdrawal
episodes. Our selected cutoff point of 0–5 withdrawals within the past 3 months
represents a reachable and desirable goal that we hypothesized would minimize the
injection risk associated with numerous withdrawal episodes.
Three stand-alone items were used to assess exposure to risky injection net-
works: (a) network size was assessed as the total number of people participants
reported injecting in the presence of within the past 3 months (range 1–150); (b) risk
with network was evaluated by asking participants how often they found themselves
in a drug-taking situation in which only syringes that had been used by others were
available; and (c) safety with network was assessed as the percentage of network
members to whom participants provided sterile syringes. The safety with network
indicator was calculated by dividing a participant’s response to the question “How
many injectors did you provide with sterile syringes?” by his or her injection net-
Primary Outcomes: Drug Intake and Perceived Control Over Drug Use. Partici-
pants’ frequency and amount of drug intake were assessed with two items: (a) the
average dollar amount the participant reported spending on drugs on a given day
(ranging from $0 to $500); and (b) the participant’s average number of weekly injec-
tions (calculated by multiplying the number of days the participant reported inject-
ing in a typical week by the number of times he or she reported injecting in a typical
Participants’ perceived ability to control drug intake was assessed with a single
item. In order to facilitate statistical analysis for this stand-alone item in light of our
modest sample size, the four response categories for this item—“No Control,” “Very
Little Control,” “Moderate Control,” and “A Lot of Control”—were recoded into
two categories—“No Control” or “Very Little Control” versus “Moderate Control”
or “A Lot of Control.”
STAYING SAFE INTERVENTION 151
Primary Outcomes: Injection Risk Behavior. We inquired about six risky practices
associated with parenteral infection (Pouget, Hagan, & Des Jarlais, 2012). The first
item asked whether or not the participant had used, even once, a syringe that had
previously been used by someone else. The remaining five risky practices were as-
sessed by inquiring how many times participants (a) divided a drug solution using
a syringe (“backloading”), (b) shared cookers, (c) shared cottons, (d) shared water,
and (e) shared water containers. Responses for each of these five items were coded
as follows: 0 times = 0; 1 time = 1; 2–5 times = 2; 6–10 times = 3; 11+ times = 4. For
this analysis, responses to each of the five non-syringe-paraphernalia–related items
were recoded as a dichotomous variable: “no risky injection practices in the past 3
months” (i.e., score of 0 for each item a, b, c, and d) and “risky injection in the past
3 months” (i.e., score of ≥ 1). Given the significant HCV risk associated with sharing
injection paraphernalia, this recoding underscored an important distinction between
those participants who eliminated paraphernalia-sharing practices versus those who
continued to engage in sharing injection paraphernalia, if only a few times.
We used single degree of freedom marginal homogeneity tests for ordered data
with null distributions approximated by Monte Carlo resampling (Agresti, 2002),
as implemented in the coin package in R (Hothorn, Hornik, van de Wiel, & Zeileis,
2006, 2008), to compare responses for 12 ordinal items before and after the in-
tervention. Paired samples t tests were used to compare self-reported participation
in risk-related behaviors during the period 3 months prior to intervention and the
period 3 months after intervention. McNemar’s test was used to compare responses
for seven dichotomous items before and after the intervention. Stochastic dominance
effect sizes (Vargha & Delaney, 2000) were calculated to convey the magnitude of
changes on a common scale. For these effect sizes, a value of .50 indicates no differ-
ence and a value of 1.0 would indicate that whenever responses were different be-
fore and after the intervention, the response after the intervention was always more
favorable to risk reduction. Thus, the effect size can be interpreted as the probability
that the postintervention response was more favorable than the preintervention re-
sponse when they were different. Stochastic dominance effect sizes of 0.56, 0.64,
and 0.71 are considered small, medium, and large, respectively.
Analyses were also conducted to compare intervention completers (n = 51)
versus dropouts (n = 17) (i.e., those for whom we have no posttest data, none of
whom attended any intervention sessions) for all basic sociodemographic and pri-
mary outcome variables in order to ascertain any potential biases in retention rates.
Two-tailed, independent samples t tests or chi-square tests were conducted, as ap-
As assessed at pretest, participants (N = 68) were 78% White, 11% Latino,
4% African American, and 8% mixed race/ethnicity; 34% were female, and 75%
were currently homeless. The mean age was 32 years (SD = 9.5 years; range = 19–58
years) with 38 participants (56%) between the ages of 18 and 30 and 30 participants
(44%) age 31 years or older. Mean number of years since first injection was 12 (SD
152 MATEU-GELABERT ET AL.
= 9.4 years; range = 1–48 years); 19% had injected between 1 and 4 years; 29% for
5–10 years; and 51% for 11 or more years.
Participation rates from this pilot study strongly suggest the feasibility of our
intervention approach. No participants attended only one intervention session. Of
all recruited subjects (N = 68), most (79%; 54/68) attended at least three of the
group sessions and, of those who attended any intervention sessions (n = 59), ap-
proximately half (53%; 31/59) attended all five sessions. On average, participants
attended 84% of the five scheduled intervention sessions. Because the total sample
size is modest and there were so few participants who attended fewer than three of
the planned sessions (7%; 5/68), comparisons of intervention effects by dose were
EFFICACY OF THE STAYING SAFE INTERVENTION
As shown in Table 2, the Staying Safe Intervention showed promising evidence
of efficacy. Sample size for all analyses is based on the 51 participants who com-
pleted posttest assessments.
Using a criterion of p < .10, we found that all differences in basic sociodemo-
graphic and primary outcome variables between intervention completers (n = 51)
and those who did not attend any intervention sessions (n = 17) were nonsignificant.
Mediating Factors: Individual Determinants of Risk. Participants reported substan-
tial increases in planning skills, indicating improvement in their perceptions of their
abilities to plan ahead to avoid foreseeable injection-related risk (effect size = .73; p
Participants also reported increases in perceived motivation/self-efficacy to
avoid sharing injection paraphernalia (effect size = .67; p = .005), supporting the
notion that participants felt more empowered to make decisions that would reduce
their risk of HIV and/or HCV exposure postintervention.
Mediating Factors: Upstream Determinants of Risk. Participants also showed a sig-
nificant increase on the Keeping It Together scale, a measure of stigma management
strategies, such as maintaining a “decent” physical appearance, hiding track marks,
and distancing oneself socially from other users—strategies that may help individu-
als not to be labeled as “drug users” by the dominant society, thereby helping to
mitigate their social marginalization (effect size = .69; p = .002).
Participants did not report increases in access to material and/or emotional sup-
port provided by relatives, nonusing friends, or neighbors (effect size: 44; p = .556).
Mediating Factors: Risk Contexts. Postintervention results revealed a 27% reduc-
tion in the number of participants who suffered six or more withdrawal episodes
within the prior 3 months (effect size = .75; p < .001), suggesting that the Staying
Safe Intervention was successful in reducing participants’ exposure to withdrawal.
Despite the decrease in experiences of withdrawal, participants reported engag-
ing in fewer withdrawal prevention activities (e.g., storing money, drugs, or metha-
done for times of need) at postintervention (effect size = .34; p = .042).
Staying Safe participants demonstrated marked improvements in network risk
avoidance after the intervention. For example, participants reported a reduction,
from 14 (SD = 22) to 4 (SD = 5) in the mean number of people with whom they
STAYING SAFE INTERVENTION 153
TABLE 2. Staying Safe Intervention: Pre- and Postintervention (3 Months) Paired Samples Statistics
(n = 51)
Individual Determinants of Risk
Planning Scaleb 5.14 < .001.73
Self-Efficacy Scaleb 2.92 .005.67
Upstream Determinants of Risk
Keeping It Together scaleb 3.34.002.69
Access to Resourcesb 0.59 .556 .44
On average, how much did you spend on drugs on a given dayb
Ability to manage drug intake as “moderate” or “a lot ” of controlc
Average weekly injectionsb
4.53 < .001.80
Withdrawal Prevention Scaleb 2.08.042.34
Suffered opioid withdrawalsd 15.94 < .001.75
Number of people with whom you have injected drugsb 3.02 .004.83
Had drugs yet only syringes used by others were availabled
Percent of those with whom injected drugs provided sterile needlesb
Risky Injection Practices
Shared needles even oncec
10.89 < .001.65
Divided up drugs using a syringe (known as “backloading”)c
11.64< .001 .66
18.18 < .001.72
12.80 < .001 .70
Shared water containersc
19.20 < .001.66
Injection Risk and Drug Intake Behaviors
On average, how much did you spend on drugs on a given dayb
Average weekly injectionsb
4.53 < .001.80
Perceived ability to manage drug intake as “moderate” or “a lot ” of controlc 10.71.001 .65
Note. aStochastic dominance effect sizes of 0.56, 0.64, and 0.71 are considered small, medium, and large, respectively.
bPaired samples t test. cMcNemar test for binomial distribution. dSingle degree of freedom marginal homogeneity tests
for ordered data with null distributions approximated by Monte Carlo resampling (Hothorn, Hornik, van de Wiel, &
154 MATEU-GELABERT ET AL.
injected (effect size = .83; p = .003). Results also showed an increase from 37% to
53% in the number of participants who provided sterile syringes to all those injec-
tors with whom they injected (effect size = .67; p = .047) and an increase, from 22%
to 47%, in the number of participants who, during the prior 3 months, were never
in a drug-use situation in which only previously used syringes were available (effect
size = .69; p = .013).
Primary Outcomes: Drug Intake and Perceived Control Over Drug Use. At the
3-month follow-up, participants reported significant reductions in both their aver-
age number of weekly injections (effect size = .80; p < .001) and their average daily
drug expenditures. Before the intervention, participants spent a mean of $77 (SD:
$75) on drugs per day; after the intervention, the mean daily expenditure was re-
duced to $47 (SD: $40; effect size = .70; p = .022). Participants also reported signifi-
cantly increased perceived control over their drug intake (effect size; .65; p < .001)
after the intervention.
Primary Outcomes: Injection Risk Behaviors. The Staying Safe evaluation inquired
about six targeted risky injection practices: injecting with previously used syringes;
“backloading” (i.e., using a syringe to divide drugs with another injector); sharing
cookers; sharing cotton filters; reusing drug-dilution water; and sharing water con-
tainers. Posttest data revealed marked reductions in all of these behaviors. Partici-
pants reported a 30% drop in syringe sharing, (effect size = .65; p < .001) and a 32%
drop in “backloading” (effect size = .66; p < .001). There were also significant drops
in the sharing of nonsyringe injection paraphernalia, including a 47% decrease in
the sharing of drug cookers to prepare the drug for injection (effect size = .74; p <
.001), a 43% drop in the sharing of cotton filters (effect size = .72; p < .001), a 39%
drop in sharing water used to dilute drugs (effect size =.70; p < .001), and a 31%
drop in the sharing of water containers (effect size = .66; p < .001).
The primary goals of the Staying Safe Intervention are to reduce participants’ injec-
tion risk behaviors, particularly the sharing of injection paraphernalia, and to train
them in strategies to more effectively control their drug intake. The intervention also
aims to empower PWID to address hypothesized mediating factors—namely, up-
stream and individual determinants of risk as well as risk contexts—that may affect
their ability to engage in safer injection practices in a sustainable manner.
Participants’ high rates of retention in the Staying Safe Intervention, along with
their active engagement in the program’s group discussions, support the feasibility of
our intervention approach with active drug injectors, including those who are home-
less (most study participants).
Our findings also suggest that the Staying Safe Intervention may have contribut-
ed to significant reductions in participants’ injection risk behaviors, average number
of weekly injections, and money spent on drugs. Additionally, the holistic approach
of the Staying Safe Intervention appears to have helped PWID gain awareness of sev-
eral potentially destabilizing mediating factors while training them in strategies to
manage them. Participants demonstrated improvements in planning skills and moti-
vation/self-efficacy to avoid injection-related risk; stigma management strategies to
STAYING SAFE INTERVENTION 155
reduce the impact of drug use on their lives; and exposure to potentially hazardous
injection situations, including drug withdrawal and risky injection networks.
The observed gains, however, were not entirely uniform; on two measures, par-
ticipants’ self-reported behavior changed in an unanticipated direction. First, par-
ticipants did not report increases in social support, including access to material and/
or emotional support provided by relatives, nonusing friends, or neighbors. This
may indicate that social support is especially resistant to change, because it is not
a self-determined behavior but is fundamentally dependent on the motivations and
behavior of others. Another possibility is that participants’ efforts to reduce PWID-
associated stigma were not sufficient to change the perceptions of those within their
social network within the course of the 3-month assessment period.
Second, despite the observed decreases in experiences of drug withdrawal, par-
ticipants reported engaging in significantly fewer withdrawal prevention activities,
such as storing money, drugs, or methadone for times of need, at the postinterven-
tion time point. This finding may indicate that participants’ decreased drug intake
and drug expenditures, possibly reflecting better management of their drug use, re-
duced their exposure to drug withdrawal episodes, which in turn reduced their need
to engage in shorter-term coping tactics.
While the Staying Safe Intervention draws on existing public health interven-
tion models and experience, the unique contribution of this program is to leverage
lessons and strategies learned from “successful” (that is, HIV- and HCV-uninfected)
long-term injectors themselves to address the immediate concerns of active injectors
in terms of their own needs, priorities, and language. This evaluation of the first
generation of Staying Safe graduates suggests that the intervention may contribute
to real differences in the behaviors and skills of active drug injectors. Furthermore,
postintervention data indicating that participants reduced their number of injection
partners and increased the number of fellow injectors to whom they provided sterile
syringes also suggests that program participants carried their new skills and aware-
ness back to their injection networks, helping to teach survival skills and promote
safer behavior within their communities. Such network-based diffusion of interven-
tion messaging may be essential to the long-term control of HCV and HIV among
The results of this preliminary study should be interpreted with caution in light
of several limitations, chief among them the small sample size and pre-/posttest re-
search design. While the lack of a control group limits our ability to eliminate alter-
native explanations for the observed outcomes, the strength and consistency of the
risk reductions observed in multiple domains highlights the promise of our interven-
tion approach. Moreover, the nonexperimental research design and modest sample
size are appropriate for this early stage, exploratory study that was intended to
evaluate the feasibility and preliminary efficacy of an innovative new intervention.
Another limitation is the short follow-up period, which limits our ability to assess
the durability of participants’ improvements in safer injection practices. An addi-
tional limitation concerns the measurement of hypothesized mediators of interven-
tion efficacy, such as efforts to prevent drug withdrawal and avoid PWID-associated
stigma. Because many of these measures were developed or adapted specifically for
this study, they were validated with only a single, relatively small sample of injectors
recruited from one geographic area; therefore, the validity and reliability of these
measures in larger and more diverse groups of injectors are unknown. However, it
156 MATEU-GELABERT ET AL.
should be noted that all scales used to assess theorized mediating factors have strong
face validity in that they measure behaviors and constructs known from prior re-
search to affect injection-related risk behavior.
Despite these limitations, this evaluation suggests that the Staying Safe Interven-
tion holds significant promise for supporting drug injectors in developing effective
risk avoidance strategies. We believe the intervention was able to realize these gains
because of three critical innovations. First, the Staying Safe Intervention does not fo-
cus exclusively on the moment of injection, but on the upstream determinants of risk
behavior, such as stigma, risk networks, social support, and income, while encourag-
ing injectors to plan ahead in order to better manage the drug-related risk contexts
they are likely to face. Another innovative aspect of the program is the fact that
abstract risk reduction messaging is placed within the larger interactional context
of group injection, a setting in which most injection-related risk occurs. Third, the
intervention highlights aspects of injection practice that are often underaddressed
in harm reduction training, particularly the sharing of water and water containers,
behaviors that have been demonstrated to carry significant risk for the transmission
of HCV in particular (Doerrbecker et al., 2011, 2013).
Harm reduction programs in NYC and other urban centers of the United States
have been important contributors to significant reductions in HIV prevalence and
incidence among drug injectors; however, these programs have to date been less suc-
cessful in facilitating significant reductions in HCV infections among their clients.
Given the substantial reductions observed among Staying Safe participants in key
injection-related risk behaviors associated with HCV transmission, the Staying Safe
Intervention may have the potential to contribute to sufficient additional risk reduc-
tion to help address the seemingly intractable rates of HCV transmission among
PWID. The Staying Safe Intervention may thus provide an additional intervention
model to be implemented in tandem with other efforts, such as SEPs and OST, to
expand and bolster efforts to address the persistent HCV epidemic among PWID.
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